Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K192577
Device Classification Name
Catheter, Urethral
More FDA Info for this Device
510(K) Number
K192577
Device Name
Catheter, Urethral
Applicant
B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109 US
Other 510(k) Applications for this Company
Contact
Anita J. Nemeth
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
GBM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/19/2019
Decision Date
05/07/2020
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact